Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Phase II Randomized Controlled Trial of Concomitant Chemoradiotherapy With Standard Fractionation Compared to Hypofractionated Concomitant Chemoradiotherapy Followed by Brachytherapy, for Clinical Stage III Cervical Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070976
• Other study ID #: 019/036/ICI
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: National Institute of Cancerología
• Contact: David F Cantú-de León, Md, MSc. PhD
• Phone: +525537093156
• Email: dfcantu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main goal of this trial is to assess the safety and response rate to concomitant chemotherapy and external hypofractionated radiotherapy followed by brachytherapy in patients with clinical stage III cervical cancer. The trial will take place in the National Cancer Institute (INCan). Patients will be randomized into two groups: chemotherapy with external standard fractionated radiotherapy (45 Gy in 25 fractions) followed by brachytherapy or chemotherapy with external hypofractionated radiotherapy (37.5 Gy in 15 fractions) followed by brachytherapy.

Description:

The primary endpoint will be to assess the safety and efficacy to concomitant chemoradiotherapy followed by brachytherapy in cervical cancer clinical stage III. Secondary endpoints comprises security profile, survival rates, quality of life and related costs.

The data obtained by this protocol will allow to determine the effect of hypofractionated radiation therapy and its possible adverse effects. Side effects will be classified according to version 4.03 of CTCAE guidelines. The highest CTCAE grade will be obtained for each type of event, for each patient and the Radiation Therapy Oncology Group (RTOG) scale will be applied to evaluate the events related to conventional and hypofractionated radiotherapy, as well as brachytherapy.

Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both have been validated and available in Mexican Spanish.

Direct and indirect expenses related to the treatment will be evaluated based on the treatment costs stipulate by the institution and the information obtained by the social workers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women over 18 years old

• Cervical Cancer at IIIA, IIIB y IIIC1 FIGO´s clinical stages

• Histology: squamous, adenosquamous or adenocarcinoma

• No previous treatment

• No distance metastases, discard by Positron Emission Tomography (PET)/CT

• Functional State ECOG (Eastern Cooperative Oncology Group) 0-2

• Complete Blood count obtained at least 14 days before admission to the study with adequate bone marrow function defined as:

• Absolute neutrophil count = 1,500 cell/mm3

• Platelets = 100,000 cell/mm3

• Hemoglobin = 10.0 g/dl

• Leukocyte count = 4000 cell/mm3

• Adequate Renal Function defined as:

• Serum Creatinine = 1.5 mg/dl within 14 days before admission to the study

• Patients with HIV infection (human immunodeficiency virus) must have a CD4 cell count = 350 cells / mm3 measured within 14 days prior to study entry (no HIV test is required)

• The patient must understand the protocol and provide the specific informed consent of the study before admission

• Negative pregnancy test

Exclusion Criteria:

• Patients who had chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies

• Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum (For example, breast cancer or oral cavity cancer)

• Previous systemic chemotherapy for current cervical cancer, take into account that prior chemotherapy for a different cancer is accepted, as long as they have been at least 3 years

• Severe active or non-controlled co-morbidities, defined as:

• Unstable angina and/or congestive heart failure that required hospitalization in the last 6 months.

• Transmural myocardial infarction in the last 6 months.

• Acute bacterial or fungal infection requiring intravenous antibiotics at the beginning of the study.

• Chronic obstructive pulmonary disease exacerbation or another respiratory disease that requires hospitalization or that contraindicates the trial therapy at the time of admission.

• Crohn's disease or ulcerative colitis.

• Prior allergic reaction to cisplatin or other drugs based on platinum.

• Other factors that contraindicate experimental therapy.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Hypofractionated therapy
All patients will be treated with an external beam of 37.5 Gray in 15 fractions (2.5 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using the anterior/posterior field and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
• Standard therapy
All patients will be treated with external beam radiotherapy with 50 Gray in 25 fractions (1.8-2 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using anterior/posterior fields and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.

Locations

Country	Name	City	State
Mexico	David Cantu de Leon	Mexico City	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cancerología

Country where clinical trial is conducted

Mexico, 

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute and late toxicity	Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG	2 years
Secondary	Treatment efficacy	Hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment	2 years
Secondary	Disease-free survival rate	Number of participants dead of disease at two years according to kaplan-meyer analysis	2 years
Secondary	Overall survival rate	Number ofpParticipants dead at two years according to kaplan-meyer analysis	2 years
Secondary	Satisfaction assessed by EORTC	Assessed individual's overall satisfaction with life and general sense of personal well-being by ERTC QLQ-C30 and QLQ-CX24 questionaire	2 years
Secondary	Direct and indirect costs related to treatment.	Direct costs related to the treatment. Indirect costs related to the treatment (transport, housing, food, etc.)	2 years

External Links

•   Human papillomavirus (HPV) and cervical cancer [Internet]